Controlled oxygen administration in term newborns and young infants requiring mechanical respiratory support and oxygen therapy
Effect of automated control of oxygen administration on oxygen saturation targeting in term newborns and young infants requiring mechanical respiratory support and oxygen therapy
Murdoch Childrens Research Institute
70 participants
May 15, 2019
Interventional
Conditions
Summary
The COATI study aims to study the impact of the VDL1.1 algorithm for automated control of inspired oxygen in term newborns and young infants with respiratory insufficiency requiring mechanical respiratory support (ventilation) and oxygen therapy. Time spent within the oxygen saturation target range will be compared during 12h periods of standard manual control and automated oxygen control (using the VDL1.1 algorithm which has been built into the SLE6000 ventilator as the OxyGenie setting) in random sequence. Comparison will also be made of time spent in hypoxic (too little oxygen) and hyperoxic (too much oxygen) ranges, frequency of hypoxic and hyperoxic episodes, overall oxygen requirement and frequency of manual FiO2 adjustments. The expected outcomes/hypothesis for this study are; That, under standard clinical conditions, the VDL1.1 oxygen control algorithm will be more effective in SpO2 targeting than manual control in the two study groups, with specifically: a) a higher proportion of time within target and alarm ranges b) a reduction of time in hypoxic and hyperoxic SpO2 ranges c) fewer hypoxic and hyperoxic episodes d) need for fewer manual FiO2 adjustments
Eligibility
Inclusion Criteria16
- Term newborns with hypoxic respiratory failure, and young infants with respiratory insufficiency related to respiratory tract infection, fulfilling the eligibility criteria outlined below.
- Each participant must meet all of the following criteria in either study population (‘Study group A’ or Study group B’) to be enrolled in the study.
- Study group A: Term and near-term infants requiring mechanical respiratory support and oxygen therapy of any duration due to hypoxic respiratory failure (HRF).
- Gestation at birth greater than or equal to 35 completed weeks.
- Chronological age less than or equal to 2 months.
- HRF related to any of parenchymal lung disease, neonatal acute respiratory distress syndrome, pulmonary hypertension or diaphragmatic hernia
- Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.
- Study group B: Young infants requiring non-invasive or invasive mechanical respiratory support and supplemental oxygen therapy of any duration secondary to RTI.
- Any gestation at birth.
- Chronological age less than or equal to 9 months and corrected gestational age less than or equal to 6 months
- Respiratory insufficiency due to respiratory tract infection (viral or bacterial)
- Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.
- Supplemental oxygen therapy being administered at study entry (baseline oxygen requirement at least 30%).
- SLE6000 ventilator with OxyGenie® option available for the study.
- Research team available to commence recording.
- Agreement of treating clinicians that the participant is appropriate for study.
Exclusion Criteria2
- Cardiorespiratory instability that precludes entry into a study.
- Change in mode of respiratory support anticipated in next 24 hours.
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Interventions
Automated control of inspired oxygen therapy will be administered using a novel adaptive algorithm (VDL1.1), that has been embedded in a commercial ventilator (SLE6000) as the OxyGenie option. This device receives SpO2 input from an oximeter, compares the value with the midpoint of the desired SpO2 range, and provides an output, which is an updated value for FiO2. Automated oxygen control using the SLE6000 + OxyGenie will be compared with standard manual control in a crossover study of 24.5 hours duration. Time spent within the SpO2 target range will be compared during 12 hour periods of automated oxygen control (OxyGenie function on the SLE6000) and manual oxygen control, in random sequence, with a 30 minute washout period between the two epochs. The SpO2 target range will be 92-96% for both manual and automated control.There will be a 30 minute wash out period between interventions. A further 24.5 hour study could commence if the infant remains eligible, after a 30 minute washout. Comparison will also be made of time spent in hypoxic and hyperoxic SpO2 ranges, frequency of hypoxic and hyperoxic episodes, overall oxygen requirement and frequency of manual FiO2 adjustments. Adherence with automated control, and conversely, the use of the manual override option when in automated control, will also be assessed using the 1 Hz data log extracted from the SLE6000 ventilator.
Locations(1)
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ACTRN12619000742178